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176 device results listed.

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Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3)

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217926
Basic UDI-DI: 50552732BLBCNL30345F
Reference: BR10391
EMDN: -
EMDN description: BILIRUBIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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ConcizuTrace™ Sample Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218879
Basic UDI-DI: 50552732ACTSCKT047KQ
Reference: CZM10594
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 08:13

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ALDOLASE AND GLUTATHIONE REDUCTASE LEVEL 2 CONTROL (ALS & GLUT RED CONTROL 2)

ALDOLASE AND GLUTATHIONE REDUCTASE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218848
Basic UDI-DI: 50552732BAGRCON157B9
Reference: AGR10572
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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ALDOLASE AND GLUTATHIONE REDUCTASE CALIBRATOR (ALS & GLUT RED CAL)

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218831
Basic UDI-DI: 50552732BAGRCAL1565X
Reference: AGR10571
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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Ultra-Low PSA Control (UL PSA Control)

IVD Class CIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218787
Basic UDI-DI: 50552732CULOPSA062XC
Reference: TU10523
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA CONTROL +)

XANTHOCHROMIA CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218725
Basic UDI-DI: 50552732BXTHPON1553F
Reference: XN10505
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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BNP CONTROLS FOR BECKMAN (BNP CONTROL)

BNP CONTROLS

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218480
Basic UDI-DI: 50552732CBNPCON061FJ
Reference: CQ10520
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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SEROLOGY HBeAg POSITIVE CONTROL (HBeAg CONTROL +)

SEROLOGY HBeAg POSITIVE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217933
Basic UDI-DI: 50552732BHBPOCT140DS
Reference: SR10459
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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CONFIDANTE

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217919
Basic UDI-DI: 50552732ACONSTI017LZ
Reference: EV3879
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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CUSTOM LIQUID IMMUNOASSAY CONTROL - LEVEL 1

CUSTOM LIQUID IMMUNOASSAY CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217513
Basic UDI-DI: 50552732BLIC123180MW
Reference: LIA3148
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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CUSTOM LIQUID THERAPEUTIC DRUG CONTROL - LEVEL 1

CUSTOM LIQUID THERAPEUTIC DRUG CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217315
Basic UDI-DI: 50552732BLTDCON177KM
Reference: HD3145
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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Home Blood Sample Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217254
Basic UDI-DI: 50552732AHBLSCK042AD
Reference: EV4460
EMDN: W0501010201
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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CARDIAC CONTROL - ULTRA LOW (CRD CONTROL Ultra Low)

CARDIAC CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217117
Basic UDI-DI: 50552732BCRDCON001AS
Reference: CQ10453
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

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SEROLOGY HIV-1 P24Ag POSITIVE CONTROL (HIV-1 P24Ag CONTROL +)

SEROLOGY HIV-1 P24Ag POSITIVE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217100
Basic UDI-DI: 50552732BAGPOCO125AR
Reference: SR10458
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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SERUM INDICES (SERUM INDICES)

SERUM INDICES

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217025
Basic UDI-DI: 50552732BSEMDCE128EF
Reference: SI10448
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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Randox Discovery

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216943
Basic UDI-DI: 50552732ADISCOV018FH
Reference: RDC10000
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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EVIDENCE+

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216691
Basic UDI-DI: 50552732AEVIDEN019DW
Reference: EV4400
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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CUSTOM LIQUID SPECIFIC PROTEIN CONTROL - LEVEL 1

CUSTOM LIQUID SPECIFIC PROTEIN CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216615
Basic UDI-DI: 50552732BLSPC1218199
Reference: PS3151
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL NEGATIVE)

SEROLOGY CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216493
Basic UDI-DI: 50552732BSECONT122LA
Reference: SR10351
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -)

SEROLOGY ToRCH CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216400
Basic UDI-DI: 50552732BSETECO123LF
Reference: SR10347
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details